Smoking CessationPhase 4NCT00770666
Combination Medications vs. Patch Alone for Medically-Ill Smokers
A Phase 4 study testing Nicotine patch, nicotine inhaler, bupropion and Nicotine patch in people with Smoking Cessation, run by University of Medicine and Dentistry of New Jersey at 1 site in United States.
Trial summary
Randomized clinical trial to evaluate a flexibly-dosed-3-medication combination for up to 6 months in smokers with medical illness Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Nicotine patch, nicotine inhaler, bupropion and Nicotine patch
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 127 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2005to Jan 2008
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- currently smoking at least 10 cigarettes per day (confirmed by high exhaled carbon-monoxide (CO))
- 18 years or older
- interested in quitting within the next 30 days
- one or more pre-defined medical illnesses (including cardiovascular disease, other vascular disease, chronic pulmonary disease, cancer, hypertension, diabetes, hyperlipidemia, and recurrent pulmonary infections)
Who cannot join
- contraindications to pharmacotherapy (including unstable angina, myocardial infarction within 2 months, severe arrhythmia, seizure disorder, serious mental illness requiring antipsychotic medications)
- current use of other tobacco products (smokeless tobacco, cigars, pipes, etc.), bupropion, clonidine, nortriptyline, or nicotine replacement medications
- unable to give consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Flexibly-Dosed Combination Pharmacotherapy Versus Standard-Dosed Nicotine Patch Alone for Smokers With Medical Illness
Randomized clinical trial to evaluate a flexibly-dosed-3-medication combination for up to 6 months in smokers with medical illness
Read the detailed description
Subjects randomly received either nicotine patch alone for a 10-week, tapering course (n=64) or the combination of nicotine patch, nicotine oral inhaler, and bupropion for an ad-lib duration (n=63).
- Conditions
- Smoking Cessation
- Being tested
- Nicotine patch, nicotine inhaler, bupropion, Nicotine patch
- Keywords
- Tobacco dependence treatment
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nicotine patch, nicotine inhaler, bupropionDrug
Patch - 21 mg - taper as able Inhaler - as needed Bupropion SR 150 mg daily
Nicotine patchDrug
21 mg daily for 6 weeks followed by 14 mg for 2 weeks and then 7 mg for 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Nicotine patch, nicotine inhaler, bupropion Receives: Drug: Nicotine patch, nicotine inhaler, bupropion |
| 2 | Active comparator | Nicotine patch Receives: Drug: Nicotine patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tobacco use abstinence
Measured: 26 week
Secondary outcomes (3)
Time to first relapse
Measured: varies
Duration of medication use
Measured: 26 weeks
Adverse clinical events
Measured: 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2008 (estimated)
- Study startSep 2005
- Primary completionDec 2007
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 127 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Medicine and Dentistry of New Jersey
- Sponsor type
- University, hospital or other
- Collaborators
- Rutgers Cancer Institute of New Jersey, Robert Wood Johnson Foundation
- Investigators
- Michael B Steinberg, MD, MPH, Principal investigator, UMDNJ-RWJMS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00770666
- Sponsor's protocol ID
- 0220055373
- Status last verified
- Oct 2008
- First submitted
- 9 Oct 2008
- Last updated
- 10 Oct 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Hajizadeh A, Howes S, Theodoulou A, Klemperer E, Hartmann-Boyce J, Livingstone-Banks J, Lindson N. Antidepressants for smoking cessation. Cochrane Database Syst Rev. 2023 May 24;5(5):CD000031. doi: 10.1002/14651858.CD000031.pub6.
PubMed 37230961Steinberg MB, Greenhaus S, Schmelzer AC, Bover MT, Foulds J, Hoover DR, Carson JL. Triple-combination pharmacotherapy for medically ill smokers: a randomized trial. Ann Intern Med. 2009 Apr 7;150(7):447-54. doi: 10.7326/0003-4819-150-7-200904070-00004.
PubMed 19349630
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Flexibly-Dosed Combination Pharmacotherapy Versus Standard-Dosed Nicotine Patch Alone for Smokers With Medical Illness
- ClinicalTrials.gov ID
- NCT00770666
- Acronym / sponsor ID
- 0220055373
- Conditions
- Smoking Cessation
- Keywords
- Tobacco dependence treatment
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 127 participants (actual)
- Lead sponsor
- University of Medicine and Dentistry of New JerseyUniversity, hospital or other
- Collaborators
- Rutgers Cancer Institute of New Jersey, Robert Wood Johnson Foundation
- Study start
- Sep 2005
- Primary completion
- Dec 2007 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 10 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Randomized clinical trial to evaluate a flexibly-dosed-3-medication combination for up to 6 months in smokers with medical illness
Detailed description
Subjects randomly received either nicotine patch alone for a 10-week, tapering course (n=64) or the combination of nicotine patch, nicotine oral inhaler, and bupropion for an ad-lib duration (n=63).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Nicotine patch, nicotine inhaler, bupropionNicotine patch, nicotine inhaler, bupropion |
| 2 | Active comparator | Drug: Nicotine patchNicotine patch |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- currently smoking at least 10 cigarettes per day (confirmed by high exhaled carbon-monoxide (CO))
- 18 years or older
- interested in quitting within the next 30 days
- one or more pre-defined medical illnesses (including cardiovascular disease, other vascular disease, chronic pulmonary disease, cancer, hypertension, diabetes, hyperlipidemia, and recurrent pulmonary infections)
Key exclusion criteria (3 listed)
- contraindications to pharmacotherapy (including unstable angina, myocardial infarction within 2 months, severe arrhythmia, seizure disorder, serious mental illness requiring antipsychotic medications)
- current use of other tobacco products (smokeless tobacco, cigars, pipes, etc.), bupropion, clonidine, nortriptyline, or nicotine replacement medications
- unable to give consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nicotine patch, nicotine inhaler, bupropionPatch - 21 mg - taper as able Inhaler - as needed Bupropion SR 150 mg daily | Drug | 1 |
| Nicotine patch21 mg daily for 6 weeks followed by 14 mg for 2 weeks and then 7 mg for 2 weeks | Drug | 2 |
Primary outcome
Tobacco use abstinence
Time frame: 26 week
3 secondary outcomes
Time to first relapse
Time frame: varies
Duration of medication use
Time frame: 26 weeks
Adverse clinical events
Time frame: 26 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2008.
- Derived from this study: PubMed 37230961Hajizadeh A, Howes S, Theodoulou A, Klemperer E, Hartmann-Boyce J, Livingstone-Banks J, Lindson N. Antidepressants for smoking cessation. Cochrane Database Syst Rev. 2023 May 24;5(5):CD000031. doi: 10.1002/14651858.CD000031.pub6.
- Derived from this study: PubMed 19349630Steinberg MB, Greenhaus S, Schmelzer AC, Bover MT, Foulds J, Hoover DR, Carson JL. Triple-combination pharmacotherapy for medically ill smokers: a randomized trial. Ann Intern Med. 2009 Apr 7;150(7):447-54. doi: 10.7326/0003-4819-150-7-200904070-00004.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael B Steinberg, MD, MPH principal investigator
UMDNJ-RWJMS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nicotine patch, nicotine inhaler, bupropion and Nicotine patch in people with Smoking Cessation, run by University of Medicine and Dentistry of New Jersey at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Oct 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tobacco use abstinence (time frame: 26 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00770666, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2008.